Trials / Completed
CompletedNCT03857919
TearCare System to Treat Dry Eye Disease
Randomized, Controlled Trial to Evaluate the Safety and Effectiveness of the TearCare® System in the Treatment of the Signs and Symptoms of Dry Eye Disease
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 235 (actual)
- Sponsor
- Sight Sciences, Inc. · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
Summary
In this study, the TearCare System will be compared with the LipiFlow Thermal Pulsation System in patients with dry eye disease. The objective is to demonstrate that the TearCare System is safe and effective in relieving the signs and symptoms of dry eye disease.
Detailed description
The primary objective of this study was to demonstrate the safety and effectiveness of a single TearCare System treatment compared to a single LipiFlow treatment in relieving the signs and symptoms of dry eye disease. This study was conducted to collect data to support a modification to the TearCare indication for use to read as follows, "The TearCare® System is indicated for the treatment of the signs and symptoms of dry eye disease (DED)."
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | TearCare | The TearCare SmartLids will be applied to the external surface of each eyelid. The TearCare System will be turned on and heat will be delivered to the eyelids for 15 minutes. Immediately following the thermal portion of the procedure, the SmartLids will be removed and the doctor will manually express the meibomian glands. |
| DEVICE | LipiFlow | The LipiFlow activators will be placed between the inner eyelid and the corneal surface of each eye. The LipiFlow System will be turned on and heat and pressure will be delivered to each eyelid for 12 minutes. |
Timeline
- Start date
- 2019-03-03
- Primary completion
- 2020-02-17
- Completion
- 2020-12-18
- First posted
- 2019-02-28
- Last updated
- 2025-10-01
- Results posted
- 2025-10-01
Locations
10 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03857919. Inclusion in this directory is not an endorsement.